An interventional study of Head-up tilt sleeping in Parkinson Disease and Parkinsonism, sponsored by Radboud University Medical Center. Active, not recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
Among 34 studies in Parkinson Disease by Radboud University Medical Center — 7 open to participants now, 13 under way, 1 of them phase 3. Parkinson Disease · Radboud University Medical Center.
Among the 34 studies in Parkinson Disease by Radboud University Medical Center, this one is the 17th largest by planned enrollment of the 22 interventional ones that give a count, is one of 7 that started in 2023, is one of 15 with no phase, reaches primary completion later than 1 of the 12 other live ones, and was the 21st registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →7 of the 34 studies in Parkinson Disease by Radboud University Medical Center are open now, in 2 countries. Recruiting first, the newest first:
Radboud University Medical Center · Sites in Netherlands
Radboud University Medical Center · Sites in United States, Netherlands
Radboud University Medical Center · Sites in Netherlands
Radboud University Medical Center · Sites in Netherlands
Radboud University Medical Center · Sites in Netherlands
By country, each count listing its studies:
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 7 started in 2023.
This study's planned enrollment of 50 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 188 across the 22 interventional studies, 133 across the 12 observational. Of the 18 that completed or were terminated, 2 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
4 of the studies in Parkinson Disease by Radboud University Medical Center that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07316296Phase 3Radboud University Medical CenterPharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach | 2027-07-01 |
| NCT06142448Radboud University Medical CenterThe Effect of Compensation Strategies on Gait Impairment in Parkinson's Disease | 2026-12-01 |
| NCT06669455Radboud University Medical CenterAn Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease | 2027-03 |
| NCT06573866Radboud University Medical CenterEnhancement of Quality of Work And Life | 2027-03-04 |
Among the 34 studies in Parkinson Disease by Radboud University Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At T0, in-clinic inclusion, we will record basic characteristics and several questionnaires, we will also perform a short tilt-table-test and standing blood pressure (BP) test. Intake is followed by one week of horizontal sleeping for baseline home-based BP measurements. Participants in the intervention group will then sleep in a head-up tilt position for two weeks each in angles 6°, 12° and 18°. At the second and final in-clinic meeting, at T1, measurements done at T0 will be repeated, complemented with an assessment of barriers and facilitators of HUTS. During HUTS daily BP measurements will be done, and data will be collected on orthostatic tolerance, nighttime urine production, subjective comfort of HUTS, falls.
Other: Head-up tilt sleeping
Follows the same structure as the intervention group, but starts with a HUTS placebo angle of 1° for two weeks, followed by two intervention angles of 6° and 12° for two weeks each. The 1°-angle serves as the control intervention.
Other: Head-up tilt sleeping
Whole-body head-up tilt sleeping (HUTS) will be carried out in three different angles, each for the duration of two weeks. Prior to the first angle the participant will sleep in a horizontal position for 1 week. The different angles will be installed using a wedge between the mattress and bed frame.
Average overnight supine blood pressure
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
Time frame: Measured four times: in week 1, 3, 5 and 7
Daily supine blood pressure
Supine blood pressure (mmHg) measured every morning directly after awakening before getting out of bed
Time frame: Daily in week 1 up to and including week 7
Orthostatic blood pressure
Standing orthostatic blood pressure test (mmHg). Measured in clinic and home-based guided by a researcher via video call.
Time frame: Measured six times: in-clinic (T0; pre-intervention), in week 1, 3, 5 and 7, and in-clinic on the day after week 7 ends (T1; post-intervention)
24h ABPM parameters
24h ABPM parameters blood pressure variability (mmHg), nocturnal blood pressure dipping (mmHg) and average daytime blood pressure (mmHg). Each of these measures will be derived from the 24 hour blood pressure measurements, and reported separately.
Time frame: In week 1, 3, 5 and 7
Orthostatic tolerance
Self-reported burden of symptoms of orthostatic hypotension (Orthostatic hypotension questionnaire (OHQ)). The score ranges from 0 to 100, with a higher number meaning worse symptoms of orthostatic hypotension.
Time frame: Week 1, 3, 5 and 7
Nocturia
Self-reported frequency of daytime and night time urination and impact on quality of life (International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N))
Time frame: Week 1, 3, 5 and 7
Subjective comfort of HUTS (head up tilted sleeping)
Self-reported tolerability of the head up tilted sleeping at different angles including questions about sleep duration, sleep quality and comfort, and feeling rested in the morning.
Time frame: Week 1, 3, 5 and 7
Falls
Self-reported falls and in case of a fall additional questions about the time and circumstances
Time frame: Week 1, 3, 5 and 7
Overnight change in body weight
Weight (kg) difference between the evening and the morning, both measured after micturition
Time frame: Daily in week 1 up to and including week 7
Nighttime urine production
Urine volume measured in a urinal (ml)
Time frame: Week 1, 3, 5 and 7
Barriers and facilitators of the intervention
Structured interview
Time frame: Immediately post-intervention (day after week 7, T1)
Timed up and go test (TUG)
Measurement of the time that the participant takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Symptoms of Parkinson's disease
Movement disorders society unified disease rating scale (MDS-UPDRS). Scores range from 0 to 199, with a higher score indicating a more severe impairment related to Parkinson's disease.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Quality of sleep
Pittsburgh Sleep Quality Index (PSQI). Score ranges from 0 to 21, with 21 indicating a worse sleep quality.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Fear of falling
Falls Efficacy Scale (FES). Scores ranges from 16 to 67, with a higher score meaning a worse fear of falling.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Subjective level of physical activity
Longitudinal Aging Study Amsterdam (LASA) Physical Activity Questionnaire (LAPAQ). Score corresponds to time spend doing physical activities. A higher score indicates a more active last two weeks.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Cardiovascular autonomic symptoms
Selected cardiovascular questions from the Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT). Scored 0 to 9, a worse score means more symptoms of orthostatic hypotension.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Experienced quality of life
Quality of life questionnaire: the Parkinson's disease questionnaire (PDQ-39). Scores range from 0 to 100, with a higher score indicating a worse quality of life.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Experienced anxiety and depression
Quality of life questionnaire: the hospital anxiety and depression scale (HADS). Scores range from 0 to 21 for depression and anxiety, a score between 0-7 means no anxiety or depression, 8-14 possibility of an anxiety or depressive disorder and 15-21 likely a depressive or anxiety disorder.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Mental health
Quality of life questionnaire: the Mental Health Continuum-Short Form (MHC-SF). Scores range from 0 to 70, with a higher score meaning a better emotional wellbeing.
Time frame: Pre-intervention (day before week 1, T0) and post-intervention (day after week 7,T1)
Plan to share: Yes — Relevant and anonymized research data will be shared in the validated research database DANS Easy (Data Archiving and Networked Services). It will also be shared with the funding foundation (MJFF).
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Study protocol and statistical analysis plan are shared with the funding foundation prior to the onset of the study. After completion of the measurements and analysis we will share the clinical study report with the funding foundation and place relevant and anonymized data on the DANS Easy database.
Access criteria: Access to the data is restricted, meaning that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2024, 17 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 17 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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